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8 Changing Environment Never Events “Never events cause serious injury or death to beneficiaries and result in unnecessary costs to Medicare and Medicaid due to the need to treat the consequences of the errors,” said CMS Acting Administrator Kerry Weems. “The steps taken today reflect our strong conviction that these events, in fact, should be prevented, and our commitment to protecting Medicare and Medicaid patients from them.” STEVENS & LEE Health Care Litigation and Risk Management Group Surgical site infection following bariatric surgery for obesity

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20 Introductory language INFORMED CONSENT TO SURGICAL PROCEDURE It is very important to [insert physician, practice name] that you understand and consent to the treatment your physician is rendering and any procedure your physician may perform. You should be involved in any and all decisions concerning surgical procedures your physician has recommended. Sign this form only after you understand the procedure, the risks, the alternatives, the risks associated with the alternatives and all of your questions have been answered. Please initial and date directly below this paragraph indicating your understanding of this paragraph. _________________________________ Patient's Initials or Authorized Representative STEVENS & LEE Health Care Litigation and Risk Management Group

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22 In Your Informed Consent Form? “In the unlikely event that one or more of the above inherent complications may occur, my physician(s) will take appropriate and reasonable steps to help manage the clinical situation and be available to me and my family to address our concerns and questions.” STEVENS & LEE Health Care Litigation and Risk Management Group

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27  First and foremost empathize!  Objective facts – what is known  What happened, why  If not yet known, say so...but follow up  Discuss what is being done to reduce further harm  If not clear about what caused injury, say so  Extension of informed consent discussion*  Answer questions you know they must have When It Is a Complication STEVENS & LEE Health Care Litigation and Risk Management Group

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30 NOVUS – Putting it all together  Understanding and evaluating bariatric surgery  Researched specific root cause of frequency and severity with an Ethicon grant  Formal endorsement from ASMBS – August 2005  Comprehensive loss control program infrastructure which has been accepted!  Bariatric surgeons across the country ARE changing the way they practice STEVENS & LEE Health Care Litigation and Risk Management Group

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31 ASMBS  Endorses NOVUS (since 2005)  Vision: Improve public health and well-being by lessoning the burden of the obesity disease and related diseases.  Founded in 1983, the purpose of the society is to encourage its members to:  Improve care and treatment of the obese and related diseases  Advance the science and understanding of metabolic surgery  Foster communication among healthcare professionals  Be the recognized authority and resource on metabolic and bariatric surgery  Advocate for health care policy that ensures patient access to high quality prevention and treatment of obesity  Be a highly valued specialty society that serves the educational and professional needs of our diverse membership STEVENS & LEE Health Care Litigation and Risk Management Group

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32 Surgical Excellence, LLC  To help general and bariatric programs, surgeons, hospitals, and centers enhance quality of care and patient safety while reducing professional liability risk  To respond to the growing need for supporting bariatric and general surgeons, and their programs from both a clinical and risk management perspective  A complimentary program to NOVUS  Helping doctors become COE  Insurance proficiency evaluations STEVENS & LEE Health Care Litigation and Risk Management Group

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34 Centers of Excellence  To survive in today’s environment, it is a must have  Eligibility is a comprehensive process that includes  Documented comprehensive program  Emphasis on results of safety  Process is  Time-consuming  Benefit from our experience  SE provides support  Becoming a COE  Mock COE site visit  SE provides a program for COE The Advisory Board Company – Horizon Scan, February 2009 STEVENS & LEE Health Care Litigation and Risk Management Group